Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

This study has been terminated.

(See statement in Detailed Description.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00282945

First received: January 25, 2006

Last updated: October 9, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2006

Last Updated Date

October 9, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00282945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

Official Title ^ICMJE

Analyzing Beta Cell Function Tests Over Time In Patients With Type 2 Diabetes Mellitus Randomized To Metformin Or Rosiglitazone

Brief Summary

The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

Detailed Description

The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Rosiglitazone
Drug: Metformin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
45-70 years of age.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).

Gender

Both

Ages

45 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00282945

Other Study ID Numbers ^ICMJE

A9001289

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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